CRYSVITA

Medicinal product

(Invented) name

CRYSVITA

Active substance (s)

Burosumabas

Strength

10 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BX05, Burosumab

Marketing authorisation holder

Kyowa Kirin Holdings B.V., Nyderlandai

Date of authorisation

2018-02-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Burosumabas	10 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
99002	85106	1085106	flakonas	N1		Receptinis	EU/1/17/1262/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-19	Registruotas